Data / Medical devices / Japan / Kaneka Corporation Tomatoh Plant
Kaneka Corporation Tomatoh Plant: FDA-registered device maker in Tomakomai-city Hokkaido, Japan, 1 PMA approval
Kaneka Corporation Tomatoh Plant is registered with the FDA (registration 3031408734) in Tomakomai-city Hokkaido, Japan. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated February 21, 1996. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031408734
- Address
- 6-253, Aza Kashiwabara, Tomakomai-city Hokkaido, Japan, 059-1362
- Owner or operator
- KANEKA CORP. (9005249)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 16, 2007
- Registered through
- 2026
- Brand names listed
- Liposorber LA-15 System, Liposorber LA-15 system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients | PBN | f | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lipoprotein, Low Density, Removal | MMY | 3 | Exporter to the US, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 21, 1996 | P910018 | LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). | MMY | 37 | June 16, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients
- All makers of Lipoprotein, Low Density, Removal
Updated June 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.